The European clinical trial Discovery, intended to find an effective treatment against Covid-19, takes longer than expected to deploy outside France due to "regulatory difficulties", said Wednesday the infectiologist Florence Ader, who pilot this ambitious project. "We do not encounter ill will, we encounter regulatory difficulties," she said during a hearing by the Senate Social Affairs Committee in Paris.
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Launched on March 22, this trial coordinated by Inserm, the French public body for medical research, to test four already existing treatments, including the controversial hydroxychloroquine, aims to include 3,200 patients with a severe form of Covid-19 hospitalized in at least seven European countries.
But it "currently has 740 patients" in thirty hospitals, including "only one outside France" in Luxembourg, said the researcher. Initially, the United Kingdom, Germany, Spain and even Belgium also wanted to participate in the study.
While "the pace of inclusion in the trial has slowed considerably in France", due to the decline in the number of new patients after seven weeks of confinement, the participation of other European countries is essential to reach the critical size that will allow '' achieve statistically significant results, she said.
However, if "no country has formally withdrawn from the discussions" to participate in the study, "it takes a long time to understand the regulatory management circuits from one country to another," said Professor Ader, calling for more "harmonization of European procedures" in clinical trials.
Dedicated envelope
For some countries, the 4,500 to 5,000 euros that each patient included in the study costs can also be a problem, she added, referring to discussions in progress with the European Union to release a dedicated envelope.
"It does not mean that it is not progressing, but it is progressing slowly," for his part told AFP the head of the Reacting research consortium, Yazdan Yazdanpanah, who deplored Friday in Le Monde these European blockages.
"We are starting" the inclusions of patients "in Austria and Portugal, and I hope Germany," he said. The Discovery trial is not a competitor to the Solidarity study launched by the World Health Organization (WHO) but it is an "offshoot", the data ultimately being intended to be shared, also explained Florence Ader , who works at the Croix-Rousse hospital, at the Hospices Civils de Lyon (HCL). "There are currently just over 1,800 patients in Solidarity (and) France is the country that has included the most in this protocol."